Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngE… (NCT03623646) | Clinical Trial Compass
CompletedPhase 2
Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.
France11 participantsStarted 2019-03-15
Plain-language summary
This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma.
In this phase II trial, patients will be assigned in one of the two treatment arms:
* Arm A (standard arm): Chemoradiotherapy arm
* Arm B (Experimental arm): Immunotherapy + Radiotherapy arm
Total duration of treatment will be 6 months (at maximum in the experimental arm).
Patients will be followed for a maximum of 2 years following the date of randomization.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Newly diagnosed, histologically proven squamous cell carcinoma of oropharynx T1 N1-N2 or T2-T3 N0 to N2 (AJCC 2018)
. HPV positive status (positive staining for p16 in immunochemistry)
. Presence of at least one measurable lesion according to RECIST v1.1 criteria (longest diameter recorded ≥10 mm with CT scan)
. No prior anticancer therapy for OSCC
. Patient eligible for definitive radiochemotherapy
. Age ≥ 18 years
. WHO performance status \< 2 i.e. 0 or 1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of patients alive without progression at 12 months.
. Previous treatment with another check-point inhibitor
. Other histologies : UCNT, p16- SCCHN, sino-nasal tumors
. Patient ineligible for Cisplatin according to the updated SmPC of the drug (including patient with auditory deficiency, patient with neuropathy induced by previous Cisplatin treatment or patient treated with prophylactic phenytoin)
. Metastatic disease
. Previous radiotherapy, except anterior strictly out of field radiotherapy, received for treatment of another primary tumor considered in remission in the past 5 years
. Participation in another therapeutic trial within the 30 days prior to entering this study
. Uncontrolled disease such as diabetes, hypertension, symptomatic congestive heart or pulmonary failure, renal or hepatic chronic diseases... (non-exhaustive list)